Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations
[...]the requirement for robustness in-vitro at an ethanol concentration of 40% seems likely to be more relevant to abuse-deterrence, while a concentration of 20% is likely a more realistic approximation for accidental ADD. [...]in-vitro results in 40% hydro-alcoholic media as required by regulatory...
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| Veröffentlicht in: | Pharmaceutical Technology 2015-10, Vol.39 (10), p.40 |
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| container_title | Pharmaceutical Technology |
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| creator | Friebe, Thomas P Asgarzadeh, Firouz Gray, Ann Hughes, Kevin Hebestreit, Johann-Philipp Rosiaux, Yvonne Yunis, Mahmud Faham, Amina |
| description | [...]the requirement for robustness in-vitro at an ethanol concentration of 40% seems likely to be more relevant to abuse-deterrence, while a concentration of 20% is likely a more realistic approximation for accidental ADD. [...]in-vitro results in 40% hydro-alcoholic media as required by regulatory authorities do not necessarily predict in-vivo behavior. |
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| fulltext | fulltext |
| identifier | ISSN: 1543-2521 |
| ispartof | Pharmaceutical Technology, 2015-10, Vol.39 (10), p.40 |
| issn | 1543-2521 2150-7376 |
| language | eng |
| recordid | cdi_proquest_reports_1810260466 |
| source | Business Source Complete (BSC) 商管财经类全文数据库(完整版); Alma/SFX Local Collection |
| subjects | Alcohol Alcoholic beverages Beverages Drug dosages Ethanol Narcotics Patients Pharmaceutical industry Physiology Polymers Regulatory agencies Stomach Working groups |
| title | Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations |
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